BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R

    MDR report key: 15392106 · Received September 9, 2022

    Report

    Report Number
    3005180920-2022-00678
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821431
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-AUG-2022. LOT 2009725: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2021. EXPIRATION DATE: 2026-02-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 18-AUG-2022: GMK-REVISION 02.07.0420SCF FIXED TIBIAL INSERT SC SIZE 4/20MM (K103170) LOT. 178515 LOT 178515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2018. EXPIRATION DATE: 2023-APR-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 2005040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2020. EXPIRATION DATE: 2025-SEP-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT 2008650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2020. EXPIRATION DATE: 2025-SEP-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.FCL16065 EXTENSION STEM - FLUTED Ø 16 L 65 (K120790) LOT 1904822: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2019. EXPIRATION DATE: 2024-NOV-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579028 GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R KNEE FEMUR JWH MEDACTA INTERNATIONAL SA 02.07.2404R 2009725 07630030821431

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention